Recruiting
Phase 2

LY3457263

Sponsor:

Eli Lilly and Company

Code:

NCT06897475

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY3457263

Placebo

Study Details

Brief summary:

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Conditions

Type 2 Diabetes

Study ID

NCT06897475

Start date

Mar 28, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have type 2 diabetes
  • Have HbA1c ≥7.5% to ≤10.5% at screening
  • Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
  • Have had a stable body weight for the three months prior to screening
  • On stable treatment dose of one of the following incretins for at least three months prior to screening:

  • Injectable semaglutide (1 and 2 milligram (mg))
  • Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)

Exclusion Criteria:

  • Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
  • Have a prior or planned surgical treatment for obesity
  • Have any of the following cardiovascular conditions within three months prior to screening:

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure
  • Have used insulin to control blood glucose within the past year (short-term use allowed)
  • Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening

  • If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
  • Have taken any medications or alternative remedies for weight loss within three months prior to screening

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY3457263 Dose 1

Participants will receive LY3457263 subcutaneously (SC)

experimental: LY3457263 Dose 2

Participants will receive LY3457263 SC

experimental: LY3457263 Dose 3

Participants will receive LY3457263 SC

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

LY3457263

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Helios Clinical Research - Phoenix

Recruiting

Phoenix, Arizona, United States, 85028

Contacts

480-372-5996

Principal Investigator:

David Francyk

Wolverine Clinical Trials

Recruiting

Santa Ana, California, United States, 92706

Contacts

714-617-2426

Principal Investigator:

Behnam Khaleghi

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

3526295800

Principal Investigator:

David Oliver

Oviedo Medical Research

Recruiting

Oviedo, Florida, United States, 32765

Contacts

407-977-2705

Principal Investigator:

Bradley Block

Balanced Life Health Care Solutions/SKYCRNG

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

770-696-4541

Principal Investigator:

Nadia Cameron, MD

Physicians Research Associates

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

678-252-2375

Principal Investigator:

Ola Odugbesan

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Contacts

470-317-3604

Principal Investigator:

Dwight Blake

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

6784945735

Principal Investigator:

Bram Wieskopf

Elite Clinical Trials

Recruiting

Rexburg, Idaho, United States, 83440

Contacts

208 356-8977

Principal Investigator:

Brian Beesley

Investigators Research Group

Recruiting

Brownsburg, Indiana, United States, 46112

Contacts

3178528280

Principal Investigator:

Kenneth Maynard

Clinical Research of Philadelphia

Recruiting

Pennington, New Jersey, United States, 08534

Contacts

215-676-6696

Principal Investigator:

Taher Modarressi

NYC Research INC

Recruiting

Long Island City, New York, United States, 11106

Contacts

516-574-9232

Principal Investigator:

Anastasios Manessis

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Principal Investigator:

Lina Leykina

Southgate Medical Group

Recruiting

West Seneca, New York, United States, 14224

Contacts

7167121004

Principal Investigator:

Brian Snyder

Lucas Research, Inc.

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

252-222-5700

Principal Investigator:

Kathryn Lucas

Shelby Clinical Research

Recruiting

Shelby, North Carolina, United States, 28150

Contacts

9805529230

Principal Investigator:

Christian Martin

Providence Health Partners-Center for Clinical Research

Recruiting

Dayton, Ohio, United States, 45439

Contacts

937-297-8994

Principal Investigator:

Paul Opsahl

Alliance for Multispecialty Research, LLC

Recruiting

Norman, Oklahoma, United States, 73069

Contacts

4057018999

Principal Investigator:

Lisa Connery

Frontier Clinical Research, LLC

Recruiting

Scottdale, Pennsylvania, United States, 15683

Contacts

724-220-5281

Principal Investigator:

Tiffany Pluto

Juno Research

Recruiting

Houston, Texas, United States, 77040

Contacts

713-779-5494

Principal Investigator:

Damaris Vega

Southern Endocrinology Associates

Recruiting

Mesquite, Texas, United States, 75149

Contacts

214-693-0904

Principal Investigator:

Sumana Gangi

Texas Diabetes & Endocrinology, P.A.

Recruiting

Round Rock, Texas, United States, 78681

Contacts

512-334-3505

Principal Investigator:

Srujana Yada

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

210-545-4900

Principal Investigator:

Michelle Welch

Texas Valley Clinical Research

Recruiting

Weslaco, Texas, United States, 78596

Contacts

956-431-8090

Principal Investigator:

Eduardo Luna

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

4258696828

Principal Investigator:

Chad Crystal

Centricity Research Brampton Endocrinology

Recruiting

Brampton, Canada, L6S 0C6

Contacts

905 595 0560

Principal Investigator:

Harpreet Bajaj

Ecogene-21

Recruiting

Chicoutimi, Canada, G7H 7K9

Contacts

418-545-1252

Principal Investigator:

Daniel Gaudet

Winterberry Research Inc.

Recruiting

Hamilton, Canada, L8J 0B6

Contacts

365-366-6267

Principal Investigator:

Steven Zizzo

Viacar Recherche Clinique

Recruiting

Longueuil, Canada, J4H 4B9

Principal Investigator:

Genevieve Mathieu

G A Research Associates

Recruiting

Moncton, Canada, E1G 1A7

Contacts

506-852-9865

Principal Investigator:

Jocelyn Cormier

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Canada, N7T 4X3

Contacts

1 (519) 344-6612

Principal Investigator:

John O'Mahony

Maple Leaf Research

Recruiting

Toronto, Canada, M5G 1K2

Contacts

4164657936

Principal Investigator:

Graham Smith

Diabetes Heart Research Centre

Recruiting

Toronto, Canada, M6G 1M2

Contacts

4169245871

Principal Investigator:

Luis Noronha

Fadia El Boreky Medicine

Recruiting

Waterloo, Canada, N2J 1C4

Contacts

519-569-7592

Principal Investigator:

Fadia El Boreky

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Obesity
  • Overweight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-14.